BIOPESTICIDES REGISTRATION ACTION DOCUMENT

Citral

3,7-Dimethyl-2,6-Octadienal

 PC Code : 040510

U.S. Environmental Protection Agency

Office of Pesticide Programs

Biopesticides and Pollution Prevention Division

June 20, 2011
Citral

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Biopesticides Registration Action Document

TABLE OF CONTENTS

I. EXECUTIVE SUMMARY:................................................................................................. 5

II. ACTIVE INGREDIENT OVERVIEW............................................................................... 7

III. REGULATORY BACKGROUND..................................................................................... 7

A. Classification ........................................................................................................................ 7

B. Food Clearances and Tolerances........................................................................................ 7

IV. RISK ASSESSMENT........................................................................................................... 7

A. Active Ingredient Characterization.................................................................................... 7

1. Toxicology.............................................................................................8

2. Dose Response Assessment............................................................................................. 10

3. Drinking Water Exposure and Risk Characterization.....................................10

4.. Occupational, Residential, School and Day Care Exposure and Risk 

Characterization ............................................................................................................. 10

5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation

10

6. Cumulative Effects.......................................................................................................... 11

7. Risk Characterization..................................................................................................... 11

C. ENVIRONMENTAL ASSESSMENT.............................................................................. 11

1. Ecological Hazards.......................................................................................................... 11

2. Environmental Fate and Ground Water Data ............................................................. 11

3. Ecological Exposure and Risk Characterization............................................12

 4. Endangered Species Assessment................................................................12

D. EFFICACY DATA............................................................................................................. 11

V. RISK MANAGEMENT DECISION............................................................................... 123

A. DETERMINATION OF ELIGIBILITY FOR REGISTRATION ................................. 13

B. Regulatory Decision.................................................................................13

C. Environmental Justice..............................................................................13

VI. ACTIONS REQUIRED BY REGISTRANTS ................................................................. 12

A. Reporting of Adverse Effects.....................................................................14

VII. Appendix A. DATA REQUIREMENTS (40 CFR PART 158)....................................... 13
Citral

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VIII. APPENDIX B. Product Specific Information..................................................18

IX. APPENDIX C. References................................................................................................... 15
Citral

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BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM

Office of Pesticide Programs:

Biopesticides and Pollution Prevention Division

Biochemical Pesticides Branch (BPB)

Branch Chief

Linda A. Hollis, M.S.

Health Effects/Nontarget Organisms

Russell S. Jones, Ph.D., Senior Biologist

Senior Regulatory Specialist

Leonard S. Cole, Jr. M.S.
Citral

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I. EXECUTIVE SUMMARY:

Citral is a technical grade active ingredient/manufacturing use product to be used in end-use 

products that repel mosquitoes, biting flies, and biting midges. Citral is either of, or a mixture of, 

a pair of terpenoids. The two compounds are double bond isomers. The E-isomer is known as 

geraniol or citral A. The Z-isomer is known as neral or citral B. Geraniol is a monoterpenoid C10 (branched) alcohol found widely as a chief constituent in essential oils including ilang-ilang 

oil, palmarosa oil, geranium oil, orange flower oil, lemongrass oil, hops oil, and lavender oil. It is 

a clear to pale-yellow liquid with a boiling point of 230° C, is insoluble in water, soluble in 

alcohol, ether and most common organic solvents It possesses a rose-like odor, and it is used in 

perfumes and flavoring. Nerol is the cis-isomer of geraniol. Geranial and neral are the 

corresponding aldehydes. Citronellol is the dihydrogeraniol and citronellal is the corresponding 

aldehyde. Citral is the major constituent of lemongrass oil, verbena oil, lemon oil, nikkel oil, 

lime oil, ginger oil, and other essential plant oils. It is the main source of lemon odor. Neral has 

a less intense, but sweeter odor. Citral is also used in the production of retinol which is a form of 

vitamin A. 

Geraniol is a pheromone of certain species of bees, being secreted by the scent glands of worker 

bees to signal the location of nectar-bearing flowers and the entrances to their hives. Geraniol is 

a known insect repellant or deterrant.

The Biopesticides and Pollution Prevention Division (BPPD) has determined that the 

data/information submitted for Product Chemistry and Tier I Acute Toxicity for Citral satisfy the 

current guideline requirements. BPPD granted waivers/exemptions from conducting Tier I Sub 

chronic, Developmental and Mutagenicity studies (OSCPP 870.3100 to 870.5375) due to the 

nature of the a.i. and its intended uses of potential new EP products. However, BPPD notes that 

should the intended end-use applications result in different anticipated exposures to humans, the 

data requirements may need to be addressed in future submissions. BPPD also granted 

waivers/exemptions from conducting the 90-Day Dermal-Rat study (OSCPP 870.3250) based on 

low acute dermal toxicity, minimal irritation, intended low application rates, and little human 

exposure when used in accordance with USEPA/OPP approved product labeling. As for NonTarget Organisms and Environmental Fate data requirements (OSCPP 850.2100 to 850.4450), 

the applicant satisfied these requirements either by submitting acceptable data or the data were 

waived because the guideline study was not applicable. Based on this information, the Agency

has determined that registered use of Citral as a technical grade active ingredient will have a 

provisional No Adverse Effects (NAE) on threatened and/or endangered species. A 

comprehensive Endangered Species Risk Assessment will be conducted upon submission of EP 

products containing this active ingredient.

Based on the Acute Toxicity data for Citral, the active ingredient is toxicity category III. As 

stated above, Tier I Subchronic, Developmental and Mutagenicity data requirements are Not 

Applicable at this time due to the nature of the a.i. and intended uses of potential new EP 

products. EPA has no concerns for any non-target organisms exposed to Citral when used in 

accordance with approved label directions. EPA has not identified any toxic endpoints for nontarget mammals, birds, plants, aquatic, or soil organisms. There are no concerns for any 

threatened and endangered species. Given that Citral very low toxicity and presents little if any

risk to non-target organisms, EPA concludes that it is in the best interests of the public and the 

environment to issue the registration for Citral.
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The Biopesticides and Pollution Prevention Division (BPPD) has reviewed the data/information 

in support of the requirements for granting registration under Section 3(c)(5) of the Federal 

Insecticide, Fungicide and Rodenticide Act (FIFRA). It was determined that the data/information 

submitted adequately satisfy current guideline requirements (please refer to 40 CFR Subpart U § 

158.2000). 

On October 1, 2009, EPA announced a new policy to provide a more meaningful opportunity for 

the public to participate on major registration decisions before they occur. According to this new 

policy, EPA intends to provide a public comment period prior to making a registration decision 

for, at minimum, the following types of applications: new active ingredients, first food use, first 

outdoor use, first residential use; and any registration decisions for which the Agency believes 

there may be substantial public interest. 

Consistent with the new policy of making registration actions more transparent, Citral is subject 

to a 30 day comment period as a “new active ingredient”. While a final decision on registration is 

contingent upon review and consideration of public comments, EPA presently believes that 

based on the risk assessment and information submitted in support of the registration of Citral 

that it is in the best interests of the public and the environment to issue the registration for Citral. 

The basis for this preliminary decision can be found in the risk assessment for Citral, which is 

characterized in this BRAD. 
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II. ACTIVE INGREDIENT OVERVIEW

Common Name: Citral

 Chemical Names: 3,7-Dimethyl-2,6-Octadienal

Trade & Other Names: Bedoukian Citral

 CAS Registry Number: 5392-40-5 

OPP Chemical Code: 040510 

Type of Pesticide: Biochemical Pesticide (Repellent) 

III. REGULATORY BACKGROUND

On July 29, 2010, EPA received an application filed by Bedoukian Research, Inc., 21 Finance 

Drive, Danbury, CT 06810-4192 to register the product, Bedoukian Citral Technical, containing 

the new biochemical active ingredient, Citral, a mixture of a pair of terpenoids. A notice of 

receipt of this application, allowing for a 30-day comment period, was published in the Federal 

Register of November 24, 2010 (75 FR 226). No comments were received following this 

publication.

A. Classification

On September 26, 2008, the Biochemical Classification Committee determined that Citral can be 

classified as a biochemical pesticide due to its non-toxic mode of action, natural occurrence in 

the environment, and history of exposure to humans and the environment demonstrating minimal 

toxicity. 

B. Food Clearances/Tolerances 

Currently, this active ingredient is not registered for use on food or feed commodities. A 

tolerance or exemption from the requirement of a tolerance is not required.

IV. RISK ASSESSMENT

A. Active Ingredient Characterization

The new active ingredient Citral, a mixture of two terpenoids, will be formulated as an End-Use 

Product for repelling mosquitoes, biting flies, biting midgets and no-see-ums. Citral, or 3,7-

dimethyl-2,6-octadienal, is a mixture of a pair of terpenoids with the molecular formula C10H16O. 

The two compounds are double bond isomers. The E-isomer is known as geranial or citral A. 
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The Z-isomer is known as neral or citral B. Geranial has a strong lemon odor. Neral's lemon odor 

is less intense, but sweeter. Citral is therefore an aroma compound used in the perfume industry

for its citrus effect. Citral is also used as a flavor and for fortifying lemon oil. It also has strong 

antimicrobial qualities and some pheromonal effects in insects. Citral is a simple compound that 

has low mammalian acute toxicity is likely to degrade rapidly in the environment. 

Descriptions of the product formulation and production process, as well as the formation of 

impurities, were examined by BPPD and found to be acceptable in meeting current guideline 

standards.

All product chemistry data requirements for registration of Citral have been satisfied. 

B. Human Health Assessment

1. Toxicology

For acute toxicity data requirements, toxicity categories are assigned based on the hazard(s) 

identified from studies and/or information on file with the Agency. The active ingredient is 

classified into Toxicity Category I, II, III or IV where Toxicity Category I indicates the highest 

toxicity and Toxicity Category IV indicates the lowest toxicity. 

Adequate mammalian toxicology data/information is available to support registration of Citral. 

All toxicology data requirements for Citral have been satisfied.

a. Acute Toxicity

Acute toxicity testing is required to 1) determine systemic toxicity from acute exposure via the 

dermal, inhalation and oral routes, 2) determine irritant effects from exposure to the eyes, and 3) 

determine the potential for skin sensitization (allergic contact dermatitis). 

Tier I acute toxicity studies submitted and reviewed showed that Citral is a toxicity category III 

(slightly toxic) compound via acute dermal routes of exposure, based on testing at a limit dose of 

2250 mg a.i./kg. Citral falls in Toxicity Category IV (not toxic) for acute inhalation toxicity, 

primary dermal irritation, and primary eye irritation. Citral is not an eye irritant, and definitive 

submitted information confirmed that Citral is a not a dermal sensitizer. 

For more information regarding acute toxicity data requirements, refer to Table 3 in Appendix A. 

b. Subchronic Toxicity 

Subchronic data is required to determine a no-observed-effect-level (NOEL) and any toxic 

effects associated with repeated or continuous exposure to a test substance for a period of ninety 

days. 

Waivers requested for the subchronic [90-day oral (OSCPP 870.3100), 90-day dermal (OSCPP 

870.3250), and 90-day inhalation (OSCPP 870.3465)] were granted by BPPD, based on the

product’s toxicological and exposure profile below.

i. Low acute dermal toxicity (>2000 mg/kg; Tox Category III);
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ii. Minimal dermal irritation (Toxicity Category IV); 

iii. Intended low application rates;

iv. Products containing Citral as an active ingredient are not intended for purposeful 

application to human skin, and use of products containing Citral would not result in 

comparable prolonged human exposure when used in accordance with approved product 

labeling. 

The two terpenoids comprising the active ingredient Citral, are double bond isomers containing 

10 carbon atoms. Citral is a mixture of two aldehydes that have the same molecular formula but 

different structures. The aforementioned aldehydes are relatively simple compounds that have 

low mammalian acute toxicity and are likely to degrade rapidly in the environment. For more 

information regarding the subchronic data requirements, refer to Table 3 in Appendix A. 

 c. Developmental Toxicity and Mutagenicity

BPPD granted waivers for Tier I Sub chronic, Developmental and Mutagenicity data

requirements (OSCPP 870.3100 to 870.5375) due to the nature of the a.i. and its intended uses in

potential new EP products (insect repellents). 

d. Tier II/Tier III 

The data requirements were not required due to the nature of the a.i. and its intended uses in

potential new EP products (insect repellents).

e. Effects on the Endocrine System

As required under FFDCA section 408(p), EPA has developed the Endocrine Disruptor 

Screening Program (EDSP) to determine whether certain substances (including pesticide active 

and other ingredients) may have an effect in humans or wildlife similar to an effect produced by

a “naturally occurring estrogen, or other such endocrine effects as the Administrator may

designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect.

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the first 

group of 67 chemicals, which contains 58 pesticide active ingredients and nine inert ingredients. 

This list of chemicals was selected based on the potential for human exposure through pathways 

such as food and water, residential activity, and certain post-application agricultural scenarios. 

This list should not be construed as a list of known or likely endocrine disruptors.
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Citral is not among the group of 58 pesticide active ingredients on the initial list to be screened 

under the EDSP. Under FFDCA section 408(p) the Agency must screen all pesticide chemicals. 

Accordingly, EPA anticipates issuing future EDSP test orders/data call-ins for all pesticide active 

ingredients. 

For further information on the status of the EDSP, the policies and procedures, the list of 67 

chemicals, the test guidelines and the Tier 1 screening battery, please visit our website: 

http://www.epa.gov/endo/.

2. Dose Response Assessment

Because no toxicological endpoints were identified, a dose response assessment was not 

required. 

3. Drinking Water Exposure and Risk Characterization

No significant exposure via drinking water is expected when Citral is used according to the 

product label directions. The active ingredient is not to be applied directly to water or to areas 

where surface water is present, and if used as labeled, is not likely to accumulate in drinking 

water. In the unlikely event that exposure via drinking water did occur, the health risk would be 

expected to be minimal, based on the low acute oral toxicity of Citral. 

4. Occupational, Residential, School and Day Care Exposure and Risk Characterization

a. Occupational Exposure and Risk Characterization

End-use products were not available for review. Therefore, occupational exposure and risk 

cannot be assessed or characterized. This assessment and characterization will be conducted 

upon receipt of an end-use product for review. 

b. Residential, School and Day Care Exposure and Risk Characterization

End-use products were not submitted for review. Therefore, residential, school, and day-care 

exposure and risk cannot be assessed or characterized. This assessment and characterization will 

be conducted upon receipt of an end-use product for review. 

5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation

There is reasonable certainty that no harm to the U.S. population will result from aggregate 

exposure to Citral. This includes all exposures for which there is reliable information. The 

Agency arrived at this conclusion based on the pesticide’s highly specific mode of action as a 

insect repellent, low toxicity to mammalian systems and the intended non-food use. The risk

from aggregate exposure (via oral, dermal and inhalation exposures) is negligible. 
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6. Cumulative Effects

Based on the information available to the Agency, there is no indication that toxic effects 

associated with exposure to Citral are of toxicological concern. Because of the active 

ingredient’s low toxicity, cumulative effects with other substances that share a common 

mechanism of toxicity are not expected. 

7. Risk Characterization

The Agency considered human exposure to Citral in light of the relevant safety factors in FQPA 

and FIFRA. A determination has been made that no unreasonable adverse effects to the U.S. 

population in general, and to infants and children in particular, will result from the use of Citral

when label instructions are followed. 

C. ENVIRONMENTAL ASSESSMENT

1. Ecological Hazards

Adequate non-target toxicology data/information are available to support registration of Citral. 

All non-target toxicology data requirements for Citral have been satisfied.

Non-Target Organisms and Environmental Fate data requirements were waived. 

2. Environmental Fate and Ground Water Data 

The need for environmental fate and groundwater data was not triggered because Citral acute 

toxicity studies did not trigger any additional Tier I studies. 

3. Ecological Exposure and Risk Characterization

Based on the information submitted in the data waiver requests for nontarget plants and data for 

nontarget insects, exposure and risk from the proposed use of Citral is not expected to occur for 

other nontarget organisms. 

4. Endangered Species Assessment

Based on the information discussed above, the Agency determined that registered use of Citral as 

an active ingredient will have No Adverse Effects (NAE) on threatened and/or endangered 

species. When the product is used according to label use directions, there are no concerns for 

any nontarget organisms. 

D. PRODUCT PERFORMANCE DATA (EFFICACY)

Submission of product performance data (OSCPP 810.3000) is a requirement for all pesticide 

products. Customarily, the Agency requires efficacy data to be submitted for review only in 

connection with the registration of products directly pertaining to the mitigation of disease 

bearing human health organisms and certain designated quarantine pests, i.e., ticks, mosquitoes, 
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fleas, Mediterranean fruit flies, gypsy moths, Japanese beetles, etc. For a list of organisms 

considered by the Agency as “public health pests”, please refer to Pesticide Registration Notice 

2002-1 (http://www.epa.gov/PR_Notices/pr2002-1.pdf). 

No end-use products were available for review. Therefore, product performance (efficacy) could 

not be evaluated. 

V. Risk Management Decision

A. Determination of Eligibility for Registration

Section 3(c)(5) of FIFRA provides for the registration of new active ingredients if it is 

determined that: (A) its composition warrants proposed claims; (B) its labeling and other 

materials comply with the requirements of FIFRA; (C) it will perform its intended function 

without unreasonable adverse effects on the environment; and (D) when used in accordance with 

widespread and commonly recognized practice, it will not generally cause unreasonable adverse 

effects on the environment. 

The four criteria of the Eligibility Determination for Pesticidal Active Ingredients are satisfied by 

the science assessments supporting products containing Citral. Such products are not expected to 

cause unreasonable adverse effects and are likely to provide protection as claimed when used 

according to label instructions. Therefore, Citral is eligible for registration for the labeled uses. 

B. Regulatory Decision

The data submitted fulfill the registration requirements of Citral for use as an insect repellent. 

Refer to Appendix B for product-specific information.

1. Conditional/Unconditional Registration

All data requirements are fulfilled, and EPA has determined that unconditional registration of 

Citral is appropriate.

C. Environmental Justice

EPA seeks to achieve environmental justice—the fair treatment and meaningful involvement of 

all people regardless of race, color, national origin, or income—with respect to the development, 

implementation, and enforcement of environmental laws, regulations, and policies. At this time, 

EPA does not believe that use of Citral pesticide products will cause harm or a disproportionate 

impact on at-risk communities.

For additional information regarding environmental justice issues, please visit EPA’s website at

http://www.epa.gov/compliance/environmentaljustice/index.html.

VI. ACTIONS REQUIRED BY REGISTRANTS

EPA evaluated all data submitted in connection with the registration of the Citral pesticide 

products and determined that these data are sufficient to satisfy current registration data 
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requirements. At this time, no additio

products. For new uses and/or changes to existing uses, EPA may require additional data. 

Notwithstanding the information stated in the previous paragraph, it should be clearly understood 

that certain specific data are required to be reported to EPA as a requirement for maintaining the 

Federal registration for a pesticide product. A brief summa

below. 

A. Reporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), r

must be submitted to EPA.

B. Reporting of Hypersensitivity Incidents

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the Agency under the provisions of 40 CFR Part 

VII. Appendix A. Data Requirements (40 CFR Part 158

*NOTE: Master Record Identification (

representative of supporting data for the original registration of the product containing this active 

ingredient. Subsequent to this registration, there may be additional MRIDs th

registration of other products containing this active ingredient. 

Structures and Chemical Data for 

Citral

Document

o additional data must be submitted to EPA for these particular 

products. For new uses and/or changes to existing uses, EPA may require additional data. 

Notwithstanding the information stated in the previous paragraph, it should be clearly understood 

that certain specific data are required to be reported to EPA as a requirement for maintaining the 

Federal registration for a pesticide product. A brief summary of these types of data are listed 

eporting of Adverse Effects

Pursuant to FIFRA section 6(a)(2), reports of all incidents of adverse effects to the environment 

Reporting of Hypersensitivity Incidents

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

must be reported to the Agency under the provisions of 40 CFR Part 158.2050(d).

Appendix A. Data Requirements (40 CFR Part 158-Subpart U)

ter Record Identification (MRID) numbers listed in the following tables are 

representative of supporting data for the original registration of the product containing this active 

ingredient. Subsequent to this registration, there may be additional MRIDs that support 

registration of other products containing this active ingredient. 

Structures and Chemical Data for Citral

Citral

tted to EPA for these particular 

products. For new uses and/or changes to existing uses, EPA may require additional data. 

Notwithstanding the information stated in the previous paragraph, it should be clearly understood 

that certain specific data are required to be reported to EPA as a requirement for maintaining the 

ry of these types of data are listed 

eports of all incidents of adverse effects to the environment 

Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) 

158.2050(d).

numbers listed in the following tables are 

representative of supporting data for the original registration of the product containing this active 

at support 
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TABLE 1. Physical and Chemical Properties for Bedoukian Citral Technicala

Guideline Reference No./Property Description of Result Methods

830.6302 Color Pale-yellow Visual inspection

830.6303 Physical State Liquid Visual inspection

830.6304 Odor Strong, lemon Olfactory inspection

830.6313 Stability Stable for 14 days at 54°C except in the 

presence of iron. Gas chromatography

830.6314 Oxidation/Reduction: 

Chemical Incompatibility

Not required for TGAI.

830.6315 Flammability 195°C Pensky Martens closed cup

830.6316 Explodability Not required for TGAI.

Not applicable for MP, the product 

does not contain explosive ingredients.

830.6317 Storage Stability Estimated to be stable for one year at 

ambient temperatures. Based on 14 day 

tests at elevated temperatures.

One year storage stability required.

830.6319 Miscibility Not required for TGAI.

Not applicable for MP, the product is 

not to be diluted with oil or nonpolar 

solvents.

830.6320 Corrosion Characteristics Not required for TGAI

Not addressed for MP

830.6321 Dielectric Breakdown Voltage Not required for TGAI/MP

830.7000 pH Not applicable, the product is 

practically insoluble in water.

830.7100 Viscosity 2.44 CST at 25°C ATSM D445 standard method

830.7200 Melting Range -26.74°C QSAR; Experimental data per 

EPISUITE

830.7220 Boiling Range 217.44°C Experimental data per EPISuite

830.7300 Density/Relative Density/Bulk 

Density

0.885-0.891 at 25°C Anton Parr Density meter, model 

DMA 4500

830.7370 Dissociation Constant in Water Not applicable, the product is not pure 

active ingredient.

830.7550 Partition Coefficient Log Pow 3.45 QSRA: EPISuite

830.7840 Water Solubility 1340 mg/L at 37°C

1101 mg/L at 25°C

QSAR: EPISuite (WSKOW 

v1.41)

830.7950 Vapor Pressure 0.0913 mm Hg at 25°C QSAR: EPISuite

830.2240 Photolysis (water) 1.14 years Sunlight epsilon = 6.25x103

at 

300 nm.

835.2120 Hydrolysis pH 4 9.54 – 9.81 days

pH 7 106 - 230 

pH 9 22.8 – 30.1 days

Table 3.0. Toxicological Data for Citral Technical (98% ai)

Data Requirement LD50 Toxicity Category MRIDs

Acute Oral Toxicity

OPPTS 870.1100 6,800 mg/kg

IV

(Waiver Acceptable) 48172502

Acute Dermal Toxicity

OPPTS 870.1200 2,250 mg/kg

III

(Waiver Acceptable) 48172502

Acute Inhalation Toxicity

OPPTS 870.1300 Used extensively as 

a fragrance. 

IV

> 2 mg/L

(Waiver Acceptable)

48172502
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Table 3.0. Toxicological Data for Citral Technical (98% ai)

Data Requirement LD50 Toxicity Category MRIDs

Primary Eye Irritation

OPPTS 870.2400

Citral was irritating 

to rabbit eyes (Waiver Acceptable) 48172502

Primary Dermal Irritation

OPPTS 870.2500 Irritating to rabbits (Waiver Acceptable) 48172502

Dermal Sensitization

OPPTS 870.2600 Dermal sensitizer (Waiver Acceptable) 48172502

90-Day Inhalation 

Subchronic 

(870.3465)

Used extensively as 

a fragrance. 

IV

> 2 mg/L

(Waiver Acceptable) 48172502

Prenatal Development

(870.3700)

NOAEL = 200 

mg/kg/day. No 

teratogenicity at 68 

ppm.

(Waiver Acceptable) 48172502

Mutagenicity 

(870.5100, 870.5300, 

870.5375)

10 mg/plate 

produced negative 

results with and 

without metabolic 

activation

(Waiver Acceptable) 48172502

Reproduction

(870.3550)

Rats given 0, 40, 

200, and 1000 

mg/kg/day citral tech 

with no statistically 

significant effects. 

NOAEL=1,000mg/kg/day

48172502

MHW, Japan, 2000

Table 4.0. Ecological Toxicological Data for Citral Technical (98% ai)

Data Requirement LD50 Toxicity Category MRIDs

Acute Avian Oral Toxicity

OPPTS 850.2100; 850.2200

No oral exposure. 

Product is odorous 

repellent

(Waiver Acceptable) 48172502

Acute Fish Toxicity

OPPTS 850.1075 LC50 4.6 -10 mg/L

Moderate toxicity

(Waiver Acceptable) 48172502

Acute InvertebrateToxicity

OPPTS 850.1010 EC50 = 7 – 11 mg/L (Waiver Acceptable) 48172502

Daphnia Reproduction

OPPTS 850.1300

NOEC = 1mg/L

EC50 = 1.6 mg/L 4817250

Seedling Emergence

OPPTS 850.4100

Odorous repellent no 

direct exposure to 

plants

(Waiver Acceptable) 48172502

Vegetative Vigor

OPPTS 850.4150

Odorous repellent no 

direct exposure to 

plants

(Waiver Acceptable) 48172502

Nontarget Insect

OPPTS 870.2600

Odorous repellent no 

direct contact to 

insects

(Waiver Acceptable) 48172502

VIII. Appendix B.

For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels.

IX.Appendix C.
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REFERENCES

MRID Citation Receipt 

Date

42552800 Sun Deep, Inc. (1992) Submission of product chemistry data to support registration 

of Buzz Away. Transmittal of 1 study. 

09-Nov1992

42552801 Gill, J. (1992) Product Chemistry: Buzz Away. Unpublished study prepared by Sun 

Deep, Inc. 13 p. 

09-Nov1992

43272600 S.C. Johnson & Son Inc. (1994) Submittal of Product Chemistry Data in Support of 

Registration for Off! Moth Proofer 3. Transmittal of 1 study. 

13-Jun1994

43272601

Schinkowitch, D.; Rudin, R. (1994) Off! Moth Proofer 3: Product Chemistry Data: 

Lab Project Number: 7867P100: 7867P100-C1. Unpublished study prepared by S. 

C. Johnson & Son Inc. 30 p. 

13-Jun1994

43275600 S. C. Johnson & Son Inc. (1994) Submittal of Product Chemistry Data in Support of 

Registration of Off! Moth Proofer 4. Transmittal of 1 Study. 

13-Jun1994

43275601

Schinkowitch, D.; Rudin, R. (1994) Product Chemistry Data: Off! Moth Proofer 4: 

Lab Project Number: 7867P101: 7867P101-C1. Unpublished study prepared by S. 

C. Johnson & Son Inc. 26 p. 

13-Jun1994

43278600 L&F Products (1994) Submission of Product Chemistry Data for TRYSOL in 

Support of Registration. Transmittal of 1 study. 

22-Jun1994

43278601 Herrity, M. (1994) Product Chemistry: TRYSOL: Lab Project Number: 93.0810. 

Unpublished study prepared by L&F Products, Research Development Lab. 56 p. 

22-Jun1994

43941900

Avon Products, Inc. (1996) Submission of Product Chemistry Data in Support of 

the Application for Registration of Skin So Soft Moisturizing Outdoor Protection 

After Sun Spray. Transmittal of 1 Study. 

29-Feb1996

43941901

Garey, J.; Garrison, M.; Luo, Q.; et al. (1996) 5 Batch Analysis of Skin So Soft 

Moisturizing Outdoor Protection After Sun Spray: Lab Project Number: 7222-24. 

Unpublished study prepared by Avon Products, Inc. 129 p. 

29-Feb1996

48033000 E. I. du Pont de Nemours and Co., Inc. (2010) Submission of Product Chemistry

and Toxicity Data in Support of Risk Assessment. Transmittal of 13 Studies.

19-Feb2010

48033013

Roncaglioni, A.; Piclin, N.; Pintore, M.; et al. (2008) Binary Classification Models for 

Endocrine Disrupter Effects Mediated Through the Estrogen Receptor. SAR and 

QSAR in Environmental Research 19(7-8): 679-733.

19-Feb2010

48172500

Bedoukian Research Inc. (2010) Submission of Product Chemistry and Toxicity 

Data In Support of the Application for Registration of Bedoukian Citral Technical. 

Transmittal of 2 Studies. 

02-Aug2010

48172501

Maher, M. (2010) Application for Pesticide Registration: Bedoukian Citral 

Technical: Product Chemistry. Unpublished study prepared by Bedoukian 

Research, Inc. 116 p.

02-Aug2010

48172502

Maher, M. (2010) Application for Pesticide Registration: Bedoukian Citral 

Technical: Toxicity Testing. Unpublished study prepared by Bedoukian Research, 

Inc. 399 p.

02-Aug2010

48265800

Whitmire Micro-Gen Research Laboratories, Inc. (2010) Submission of Product 

Chemistry, Toxicity and Efficacy Data in Support of the Application for Registration 

of TC-314. Transmittal of 26 Studies.

19-Oct2010

48265813 Snell, E.; Smith, T.; Garrett, B. (2010) Efficacy of TC-314 (0.5% Chlorfenapyr), 19-Oct-
Citral

Page 17 of 17

Biopesticides Registration Action Document

Phantom Pressurized Insecticide (0.5% Chlorfenapyr) and Mother Earth Exempt 

Contact Insecticide (6.0% geraniol, 0.5% Lemongrass Oil) When Applied as Direct 

Spray Applications to Carpenter Bees (Xylocopa virginica). Project Number: 

BASF/1653/1663, 2687, 1653. Unpublished study prepared by Snell Scientifics, 

LLC. 32 p.

2010

X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS

a.i. Active Ingredient

BPPD Biopesticides and Pollution Prevention Division

BRAD Biopesticide Registration Action Document

CFR Code of Federal Regulations

cm3cubic centimeter

CSF Confidential Statement of Formula

°C degrees Celsius

EDSP Endocrine Disruptor Screening Program

EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee

EPA Environmental Protection Agency (the “Agency”)

FFDCA Federal Food, Drug, and Cosmetic Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FQPA Food Quality Protection Act

FR Federal Register

g gram

kg kilogram

L liter

LD50 median lethal dose. A statistically derived single dose that can be expected 

to cause death in 50% of the test animals when administered by the route 

indicated (oral, dermal, or inhalation). It is expressed as a weight of 

substance per unit weight of animal (e.g., mg/kg).

MRID No. Master Record Identification Number

mg milligram

mL milliliter

MP manufacturing-use product

MPCA microbial pest control agent

NE “No Effect”

NIOSH National Institute for Occupational Safety and Health

OPP Office of Pesticide Programs

OPPTS Office of Prevention, Pesticides, and Toxic Substances

PCR polymerase chain reaction 

PPE personal protective equipment

 TGAI technical grade of the active ingredient